Digestive enzyme cartridge cleared for use in children

Alcresta Therapeutics, Inc. has received 510(k) clearance from the FDA for the use of its digestive enzyme cartridge Relizorb in pediatric patients as young as 5 years old with fat malabsorption, according to a press release.

Already cleared for use in adult patients in 2015, Relizorb is the only external digestive enzyme therapy that mimics the normal pancreatic function of lipase, an enzyme critical to the digestion of dietary fats that accounts for as much as 90% of fat breakdown by the body, according to the release. Without the ability to absorb fats, these individuals often must supplement their oral food intake with administered enteral tube feedings.

Relizorb increases fat absorption by breaking down fats found in enteral nutrition formulas, which can increase the chance of patients getting important calories and healthy fats that may have otherwise passed unabsorbed through the body. Data from the 497 Study, a recent pivotal clinical study that evaluated Relizorb, supported the FDA clearance, demonstrating the efficacy and safety of using the enzyme cartridge to correct shortages of healthy fats that are usually unabsorbed.

“This clearance represents a significant milestone for children who suffer from fat malabsorption,” Daniel Tassé, CEO of Alcresta Therapeutics, said in the release. “FDA clearance for extending the use of Relizorb into the pediatric population is a significant step forward in addressing the nutritional challenges confronting this critically-ill population.”

Disclosures: Tassé is the CEO of Alcresta Therapeutics.